search
Back to results

Effect of Pumpkin Seed Oil or Pumpkin Seeds on Blood Pressure and Menopausal Symptoms in Postmenopausal Women

Primary Purpose

Hypertension, Dyslipidemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pumpkin seed oil
Pumpkin seeds
Sponsored by
Texas Woman's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Non-hypertensive with blood pressure less than140/90 mmHg
  • Post menopausal women or had a bilateral oophorectomy

Exclusion Criteria:

  • Hypotensive women with BP <90/60
  • Taking medications to manage blood pressure and blood lipids
  • Taking estrogen supplements or on hormone replacement therapy
  • Taking pumpkin seed oil supplements
  • Consuming pumpkin seeds more than ¼ cup a month
  • Diagnosed with depression and taking antidepressants

Sites / Locations

  • Texas Woman's University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pumpkin seed oil

Pumpkin seeds

Arm Description

Pumpkin seed oil (1g) capsules - 2 capsules per day for 12 weeks

Packet of pumpkin seeds (4.1 grams /~0.15ounces) - 1 pack per day for 12 weeks

Outcomes

Primary Outcome Measures

Change in systolic and diastolic blood pressure

Secondary Outcome Measures

Change in Total Cholesterol level (mg/dl)
Change in Plasma Triglycerides (mg/dl)
Change in Plasma High-Density Lipoprotein Cholesterol (mg/dl)
High-density Lipoprotein-C
Change in Plasma Low-Density Lipoprotein Cholesterol (mg/dl)
Change in C-reactive protein (CRP)
Change in Endothelial Function
Endothelial function will be assessed using a computer based non-invasive peripheral arterial tonometer (Endo-PAT 2000, Itamar Medical Ltd.).

Full Information

First Posted
March 21, 2016
Last Updated
May 2, 2018
Sponsor
Texas Woman's University
search

1. Study Identification

Unique Protocol Identification Number
NCT02727036
Brief Title
Effect of Pumpkin Seed Oil or Pumpkin Seeds on Blood Pressure and Menopausal Symptoms in Postmenopausal Women
Official Title
Effect of Supplementation With Pumpkin Seed Oil Versus Pumpkin Seeds on Blood Pressure and Menopausal Symptoms in Non-hypertensive Postmenopausal Women
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
August 1, 2015 (Actual)
Primary Completion Date
June 16, 2017 (Actual)
Study Completion Date
November 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Texas Woman's University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this randomized control trial is to compare the effect of pumpkin seed oil 2g/day with pumpkin seeds given as a dose of 1½ teaspoons/ 4.1 grams a day to provide 2g of lipid (equivalent to 2 grams of oil) on BP (systolic and diastolic), endothelial function, serum lipids, C-reactive protein (CRP) concentrations, and menopausal symptoms in postmenopausal women.
Detailed Description
At the onset of menopause CVD rates increase in women. A beneficial effect of pumpkin seed oil on blood pressure has been observed in postmenopausal women. More than 1 in 3 female adults have some form of cardiovascular disease (CVD), which is affected by blood pressure. Pumpkin seed is a good source of phytoestrogens. Phytoestrogens are compounds found in plants and are comparable to human estrogen, capable of producing estrogenic effects. Studies in post menopausal women have demonstrated that pumpkin seed oil, at a dose of 2g per day for 12 weeks can decrease blood pressure and reduce menopausal symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Dyslipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pumpkin seed oil
Arm Type
Experimental
Arm Description
Pumpkin seed oil (1g) capsules - 2 capsules per day for 12 weeks
Arm Title
Pumpkin seeds
Arm Type
Active Comparator
Arm Description
Packet of pumpkin seeds (4.1 grams /~0.15ounces) - 1 pack per day for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Pumpkin seed oil
Intervention Description
1 gram capsule of Pumpkin seed oil.
Intervention Type
Dietary Supplement
Intervention Name(s)
Pumpkin seeds
Intervention Description
4.1 grams (1½ teaspoons/~0.15ounces) of pumpkin seeds
Primary Outcome Measure Information:
Title
Change in systolic and diastolic blood pressure
Time Frame
change measured - baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Change in Total Cholesterol level (mg/dl)
Time Frame
change measured - baseline and 12 weeks
Title
Change in Plasma Triglycerides (mg/dl)
Time Frame
change measured - baseline and 12 weeks
Title
Change in Plasma High-Density Lipoprotein Cholesterol (mg/dl)
Description
High-density Lipoprotein-C
Time Frame
change measured - baseline and 12 weeks
Title
Change in Plasma Low-Density Lipoprotein Cholesterol (mg/dl)
Time Frame
change measured - baseline and 12 weeks
Title
Change in C-reactive protein (CRP)
Time Frame
change measured - baseline and 12 weeks
Title
Change in Endothelial Function
Description
Endothelial function will be assessed using a computer based non-invasive peripheral arterial tonometer (Endo-PAT 2000, Itamar Medical Ltd.).
Time Frame
change measured - baseline and 12 weeks

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Non-hypertensive with blood pressure less than140/90 mmHg Post menopausal women or had a bilateral oophorectomy Exclusion Criteria: Hypotensive women with BP <90/60 Taking medications to manage blood pressure and blood lipids Taking estrogen supplements or on hormone replacement therapy Taking pumpkin seed oil supplements Consuming pumpkin seeds more than ¼ cup a month Diagnosed with depression and taking antidepressants
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madhura Maiya, MS
Organizational Affiliation
Texas Woman's University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carolyn Moore, PhD
Organizational Affiliation
Texas Woman's University
Official's Role
Study Chair
Facility Information:
Facility Name
Texas Woman's University
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18567058
Citation
Gossell-Williams M, Lyttle K, Clarke T, Gardner M, Simon O. Supplementation with pumpkin seed oil improves plasma lipid profile and cardiovascular outcomes of female non-ovariectomized and ovariectomized Sprague-Dawley rats. Phytother Res. 2008 Jul;22(7):873-7. doi: 10.1002/ptr.2381.
Results Reference
result
PubMed Identifier
21545273
Citation
Gossell-Williams M, Hyde C, Hunter T, Simms-Stewart D, Fletcher H, McGrowder D, Walters CA. Improvement in HDL cholesterol in postmenopausal women supplemented with pumpkin seed oil: pilot study. Climacteric. 2011 Oct;14(5):558-64. doi: 10.3109/13697137.2011.563882. Epub 2011 May 5.
Results Reference
result

Learn more about this trial

Effect of Pumpkin Seed Oil or Pumpkin Seeds on Blood Pressure and Menopausal Symptoms in Postmenopausal Women

We'll reach out to this number within 24 hrs